Electrical Engineer III — Med Device R&D & Manufacturing

Hologic, Inc.; Newark (DE); Sur place; USD 99 000 - 154 000; Plein temps

Résumé du poste

Hologic, Inc. seeks a qualified engineer to design, develop, and optimize components and processes for medical device manufacture. You will analyze equipment, establish manufacturing procedures, and collaborate with R&D and Facilities to improve efficiency and quality.

The role requires strong problem-solving, cross-functional collaboration, and experience with Lean, Six Sigma, and regulatory environments. Expect involvement in complex experiments and process improvements across multiple

Qualifications

• 5 to 8 years of relevant experience with a non-technical degree.
• 2 to 5 years of experience with a Bachelor's degree, 1 to 3 years with a Master's degree, or 0 to 1 years with a PhD.
• Experience with schematic capture and PCB layout software.
• Automation experience, including implementation of automated manufacturing cells or production lines.
• Experience in FDA-regulated medical device environment is highly desirable.
• Experience supporting rapid scale-up of new products or manufacturing operations is beneficial.

Responsabilités

• Performs complex experiments that may require coordination of other engineers or technicians.
• Actively participates in R&D projects by providing design input and ensuring projects can be translated into cost-effective production processes.
• Responsible for the manufacturing performance of assigned product line(s).
• Establishes fabrication and assembly procedures to support product manufacturing and develops tooling requirements.
• Initiates and/or approves changes in design, drafting, tooling, methods, processes, and documentation affecting manufacturing operations.
• Oversees the creation and revision of SOPs and directives related to scheduling, cost control, and production performance evaluation; develops, verifies, and validates manufacturing processes.
• Supports maintenance of production equipment and collaborates on predictive maintenance programs.
• Identifies, diagnoses, prioritizes, and resolves technical issues during manufacturing operations; partners with cross-functional teams.
• Evaluates and develops process control data for trending and analysis; investigates defects and implements improvements.
• Participates in design reviews and collaborates with R&D and Manufacturing to resolve issues.
• Actively supports and adheres to the company's Quality Policy and Quality System procedures.
• Conducts process analyses and leads Kaizen Events and Process Improvement initiatives to improve efficiency and quality.
• Manages multiple projects independently.

Connaissances

Lean Six Sigma Green Belt

Root Cause Analysis

Process Improvement

Technical drawing

Cross-functional collaboration

PCB design/layout understanding

FDA compliance

Schematic capture

Formation

Bachelor's degree in Engineering or related field

Advanced degree (Master's or PhD) preferred

Outils

Schematic capture software

PCB layout software

Automation equipment

MS Office

Description du poste

Hologic, Inc. seeks a qualified engineer to design, develop, and optimize components and processes for medical device manufacture. You will analyze equipment, establish manufacturing procedures, and collaborate with R&D and Facilities to improve efficiency and quality.

The role requires strong problem-solving, cross-functional collaboration, and experience with Lean, Six Sigma, and regulatory environments. Expect involvement in complex experiments and process improvements across multiple